TRACE E-learning Implementation in Belgium

Completed

• Conditions: Respiratory Tract Infections

• Registration Number: NCT03265028
• Lead Sponsor: Universiteit Antwerpen

Brief Summary

Antibiotic resistance is a worldwide health care problem. Increasing use of antibiotics is associated with an increase in the prevalence of bacteria resistant to the antibiotic used. Reducing antibiotic use can be effected by improving antibiotic prescribing quality in two complementary ways. One is to limit antibiotic prescribing to those patients who will benefit from the treatment and two is to prescribe these patients the recommended antibiotic.

International research has shown that a web-based communication training for the prescriber combined with an interactive booklet containing relevant patient information (Genomics to combat Resistance against Antibiotics for Community acquired LRTI in Europe INternet Training for Reducing antibiOtic use (GRACE INTRO)) can significantly and safely reduce antibiotic prescribing in adults presenting to primary care with acute cough/lower respiratory tract infections (LRTI). Quality assessment of antibiotic prescribing for respiratory infections in general practice has revealed the use of far too many (broad-spectrum) antibiotics in Belgium.

In the proposed project, the investigators aspire to make Belgium the first European country to implement the most cost-effective part of the GRACE INTRO intervention (Translational Research on Antimicrobial resistance and Community-acquired infections in Europe (TRACE) e-learning, www.acutecough.org) at national level and to perform a scientifically sound assessment of the nationwide implementation on outpatient antibiotic use and societal cost.

Detailed Description

The envisaged research aims to implement the most cost-effective part of the GRACE INTRO intervention (TRACE e-learning, www.acutecough.org), i.e. a web-based communication training and an interactive patient booklet for adults presenting to primary care with LRTI, at national level. For that purpose the investigators will perform a stepped wedge cluster-randomised trial. Stepped wedge randomised trial designs involve sequential roll-out of an intervention to participants (individuals or clusters) over a number of time periods. By the end of the study, all participants will have received the intervention, although the order in which participants receive the intervention is determined at random. Over a period of one year all practices in the 10 Belgian provinces and Brussels (n=11 clusters) will get access to the intervention. The order in which the clusters receive the intervention is determined at random. The general practitioners (GPs) in the intervention phase will be invited to take an educational web-based module, including communication training, to improve prescribing of antibiotics for LRTI and will receive patient booklets to be used interactively during the consultation. The clusters not yet exposed to the intervention will serve as control group. The effect on prescribing behavior will be assessed using monthly Intermutualistic Agency (IMA, www.nic-ima.be) data. Hence, the outcome measurement will have complete response, and will not interfere with the normal routine of the eligible GPs, allowing a more valid estimate of any intervention effect. Since the training will be assessed, and not the eligible practices or GPs, IMA has the legal authority (Art. 153 of the coordinated Law of 14 July 1994) to perform the required analyses. The estimates of the efficacy of the intervention will at the same time describe its effectiveness in daily practice, which is unconventional for a randomized trial (on a behavioural intervention). Given the large sample size, the proposed trial will also provide very precise estimates.

Study Timeline

• Study First Submitted: 2017-08-25
• Study First Submitted QC: 2017-08-25
• Study First Posted: 2017-08-29
• Study Start: 2017-09-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-27
• Last Update Posted: 2019-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15802

Inclusion Criteria

• all clinicians registered as General Practitioner in Belgium

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antibiotic use (short term)	First 2 months after intervention	Number of packages for antibacterials for systemic use (ATC J01) collected at the pharmacy (reimbursement data) per 1000 inhabitants per day

Secondary Outcome Measures

Name	Time	Method
Antibiotic use (intermediate term)	3-6 months after intervention	Number of packages for antibacterials for systemic use (ATC J01) collected at the pharmacy (reimbursement data) per 1000 inhabitants per day
Antibiotic use (long term)	6-12 months after intervention	Number of packages for antibacterials for systemic use (ATC J01) collected at the pharmacy (reimbursement data) per 1000 inhabitants per day

Trial Locations

Locations (11)

GPs of Henegouwen; 🇧🇪 Mons, Henegouwen, Belgium

GPs of Limburg; 🇧🇪 Hasselt, Limburg, Belgium

GPS of Luik; 🇧🇪 Liège, Luik, Belgium

Gps of Luxemburg; 🇧🇪 Arlon, Luxemburg, Belgium

GPs of Namen; 🇧🇪 Namur, Namen, Belgium

GPs of Oost-Vlaanderen; 🇧🇪 Gent, Oost-Vlaanderen, Belgium

GPs of Vlaams-Brabant; 🇧🇪 Leuven, Vlaams-Brabant, Belgium

GPs of Waals-Brabant; 🇧🇪 Wavre, Waals-Brabant, Belgium

GPs of West-Vlaanderen; 🇧🇪 Brugge, West-Vlaanderen, Belgium

GPs of Antwerp; 🇧🇪 Antwerp, Belgium

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